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Approval to modify the protective balloon sheath. The device, as modified, will be marketed under the trade name voyager nc coronary dilatation catheter and is indicated for: 1) balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; 2) balloon dilation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction; and 3) balloon dilation of a stent after implantation.
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